Quality Engineer II

Posted 8 Days Ago
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Cartago, Cartago
In-Office
Mid level
Healthtech
The Role
The Quality Engineer II will oversee quality activities in manufacturing, conduct audits, execute validations, and support product transfers to production.
Summary Generated by Built In

We are looking for a Quality Engineer to support quality activities in manufacturing and new product transfers to production.
This role works directly with internal teams and customers, executing validations, audits, and ensuring proper implementation of manufacturing and inspection processes.
This is a hands-on position, with floor presence and support during production ramp-up.


Requirements

• Communicate directly with internal and external customers
• Conduct internal audits
• Lead multidisciplinary teams on low-complexity projects
• Execute validations and TMVs
• Independently prepare IIR and FAIR reports
• Support engineering activities with other areas (IQs, OQs, PQs, or equivalents)
• Participate in the introduction and transfer of new products to production
• Lead quality activities during product development and transfer
• Develop and improve manufacturing and inspection processes
• Make low-impact technical decisions


Benefits

• Bachelor’s degree in Engineering or related field
• 2–4 years of experience in Quality/Manufacturing (minimum 1 year)
• Experience with production transfers (required)
• Experience with validations, technical documentation, and quality reports
• Ability to read and interpret drawings/blueprints
• English level B2–C1

Top Skills

Quality Reports
Technical Documentation
Validations
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The Company
HQ: White Bear Lake, MN
172 Employees
Year Founded: 2000

What We Do

Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.​

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